Item 8.01 Other Events
On January 18, 2023, Catalyst Pharmaceuticals, Inc. (the "Company") received a
Paragraph IV Certification Notice Letter (the "Notice Letter") from Teva
Pharmaceuticals, Inc. ("Teva") advising that Teva had submitted an Abbreviated
New Drug Application ("ANDA") to the U.S. Food and Drug Administration ("FDA")
seeking authorization from the FDA to manufacture, use or sell a generic version
of FIRDAPSE® in the United States.
In the Notice Letter, Teva states that it intends to market a generic version of
FIRDAPSE® before the expiration of the Company's patents listed in the FDA
Orange Book covering FIRDAPSE®: U.S. Patent Numbers 10,626,088 (expiring
February 2037); 10,793,893 (expiring May 2034); 11,060,128 (expiring June 2032);
11,268,128 (expiring June 2032); 11,274,331 (expiring June 2032); and 11,274,332
(expiring June 2032). Teva's Notice Letter states that its ANDA contains a
Paragraph IV Certification alleging that these patents are not valid, not
enforceable, and/or will not be infringed by the commercial manufacture, use or
sale of the proposed product described in Teva's ANDA submission.
Under the Food and Drug Cosmetic Act, as amended by the Drug Price Competition
and Patent Term Restoration Act of 1984, as amended, after receipt of a valid
Paragraph IV notice, the Company may bring a patent infringement suit in a
federal district court against Teva within 45 days from the receipt of the
Notice Letter. If such a suit is commenced within the 45-day period, the Company
is entitled to a 30 month stay on the FDA's ability to give final approval to
any proposed products that reference FIRDAPSE®. In the present case, the
30-month stay is expected to preempt any final approval by the FDA on Teva's
ANDA until at least May 2026.
The Company is currently assessing the Notice Letter and intends to vigorously
defend its intellectual property rights relating to FIRDAPSE®.
On January 23, 2023, the Company issued a press release announcing the receipt
of the Notice Letter. The press release is attached to this Current Report on
Form 8-K as Exhibit 99.1 and is incorporated herein by reference.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements relating to,
among other things, the Company's intention to vigorously enforce its
intellectual property rights. Any such statements that are not statements of
historical fact may be deemed to be forward-looking statements. Words such as
"potential," "may," "expects," "intends" and similar expressions are intended to
identify these forward-looking statements. These forward-looking statements are
based on the Company's current expectations and inherently involve significant
risks and uncertainties. Actual results and the timing of events could differ
materially from those anticipated in such forward looking statements as a result
of these risks and uncertainties, which include, without limitation, those risks
and uncertainties relating to the Company's ability to successfully enforce its
intellectual property rights and to defend its patents, the possible
introduction and timing of generic competition to FIRDAPSE®, and the other risks
detailed from time to time in the Company's reports filed with the Securities
and Exchange Commission, including its Annual Report on Form 10-K for the year
ended December 31, 2021 and Quarterly Report on Form 10-Q for the quarter ended
September 30, 2022. The Company does not undertake any obligation to update any
forward-looking statements and expressly disclaims any obligation or undertaking
to release publicly any updates or revisions to any forward-looking statements
contained herein.
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Item 9.01 Financial Statements and Exhibits
(d) Exhibits
99.1 Press release issued by the Company on January 23, 2023
104 Cover Page Interactive Data File (embedded within the inline XBRL document)
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